BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OB TRACEVUE SERVER

    MDR report key: 2121191 · Received May 4, 2011

    Report

    Report Number
    9610816-2011-00216
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 13, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGM
    PMA / PMN Number
    K970456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THERE WAS NO SOUND ON THE UNIT. NO PT HARM WAS REPORTED. FURTHER INVESTIGATION BY PHILIPS SHOWED THAT THE HOSPITAL HAD MOVED A PC INTO THIS UNIT THAT WAS NOT CONFIGURED TO RECEIVE ALERTS. THE DEVICE WAS PERFORMING AS INTENDED FOR THE USER CONFIGURATION. THERE WAS NO MALFUNCTION OR LABELING PROBLEM. NOTE THAT ALARMING STATUS IS CLEARLY DISPLAYED ON THE OBTV MONITOR AND IS ADEQUATELY DESCRIBED IN THE LABELING. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO SOUND ON THE UNIT. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB TRACEVUE SERVER HGM PHILIPS MEDICAL SYSTEMS M1395E

    Patients

    Seq Age Sex Outcome Treatment
    1